Assessment of the Quality of Injectable Antibiotics in Benin.

Substandard and falsified medicines are an enormous threat to global health. Poor quality antibiotic preparations contribute to the development of antimicrobial resistance. In surgery, where the occurrence of healthcare-associated infections is high, healthcare teams need to rely on the quality of antibiotic prophylaxis to prevent infections. We assessed the quality of antibiotics used for surgical infection prophylaxis in Benin. Thirty-three samples were collected from six hospitals located in various departments in Benin. The antibiotics (powders for injection: amoxicillin + clavulanic acid, ampicillin, ceftriaxone; solutions for injection: ciprofloxacin, gentamicin, metronidazole) were assessed using visual inspection, pharmacotechnical tests (including uniformity of mass, pH measure, sterility test, and active pharmaceutical ingredient identification), and assay tests (including a simple analytical method thin layer chromatography) and complex analytical techniques (ultraviolet-visible spectrophotometry, high-performance liquid chromatography-diode-array detection, conductometry). Because the material needed for the methods recommended by the pharmacopeias to assess the dosage of gentamicin was not available, we developed and validated a conductometry method. Results showed that 97% (n = 32) of the samples passed visual inspection; 100% (n = 33) of the samples passed the pharmacotechnical tests, identification of active ingredients, and sterility test; 88% (n = 29) passed the test for percentage of active pharmaceutical ingredients. Overall, 15% of the samples did not pass the quality test (3% on visual inspection and 12% for excess active ingredients). Although most of the samples passed the quality tests, it appears important to perform routine quality control for intravenous medicines.

Aqueous extract of Pedalium murex D. Royen ex L. leafy stem protects against lead induced testicular toxicity in Wistar rats.

OBJECTIVES: Lead exposure seriously impairs male reproductive function. The protective capacity of Pedalium murex leafy stem and fruit aqueous extracts against lead testicular toxicity is evaluated to find herbals drugs able to improve semen quality. METHODS: Phytochemical screening were performed according to classical methods. Twenty four male rats were divided into four groups of six rats each and received the following treatments via oral route: distilled water; 0.2% lead acetate in drinking water; 0.2% lead acetate in drinking water with 400 mg/kg P. murex aqueous leafy stem extract; 0.2% leaded water with 400 mg/kg P. murex aqueous fruit extract. Treatments were administered for 70 days. Body and reproductive organs weights, sperm parameters and testicular histological sections of each group were examined. RESULTS: Flavonoids, tannins, coumarins, alkaloids, and lignans were found in both extracts. Lead intoxication reduced sperm motility and count but increased the percentage of morphologically abnormal sperms. The germinal epithelium of seminiferous tubules histoarchitecture was disorganized by lead. The leafy stem extract was effective in reducing lead induced testicular disruption whereas fruit has not shown any beneficial effect. CONCLUSIONS: P. murex leafy stem aqueous extract is effective against semen alterations caused by lead.

A comparative study of Caesalpinia bonduc (L.) Roxb. root extracts on sexual behaviour in male Wistar rats.

Caesalpinia bonduc is among the traditionally used plant in Benin, for its enhancement of male sexual activity. This study was undertaken to investigate the potential effect of C. bonduc root extracts on sexual behaviour of male Wistar rats. For that, thirty-six rats were allocated into six groups and orally treated with dimethyl sulfoxide (control), Sildenafil citrate (standard) and C. bonduc root extracts (hexane, ethyl acetate, ethanol and methanol) orally for twenty-eight days. Sexual behaviour parameters such as intromission frequency, intromission latency, mount latency and mount frequency were evaluated on day 0, 14 and 28. After the study completion, the body and reproductive organ weights as well as testicular histology and testosterone level were recorded. C. bonduc root extracts treatments had no significant effect on the body weight of rats. Enhancement in sexual behaviour was observed in ethanolic extract treated rats. An significant increase in mount frequency and intromission frequency as well as significant reduction in mount latency and intromission latency were noticed for ethanolic extract. The same extract caused an improvement in testosterone levels, relative testes weight and histological architecture. The findings demonstrate the aphrodisiac potential of C. bonduc root and lend support to the folkloric use as aphrodisiac.

Evaluation de la qualité nutritionnelle des farines infantiles fabriquées et vendues au Bénin

La malnutrition chez les enfants a atteint des proportions inquiétantes dans les pays en voie de développement y compris le Bénin. Cette étude s'est inscrite dans le cadre de la lutte contre les carences en nutriments, dans la mesure où promouvoir des farines infantiles de bonne qualité nutritionnelle semble être l'une des meilleures voies d'amélioration du statut nutritionnel du jeune enfant. L'objectif était d'évaluer la qualité nutritionnelle des farines infantiles commercialisées au Bénin. Il s'agissait d'une étude transversale qui a porté sur 10 farines de 2ème âge, dont 8 locales et 2 importées, considérées comme référence. Les teneurs en nutriments ont été évaluées en suivant les méthodes de dosage de référence. Les résultats ont montré une non-conformité de la composition de ces farines aux normes du Codex Alimentarius, sauf en ce qui concerne les teneurs en énergie et en protéine. Sur le plan qualitatif, les protéines apportées par ces aliments de complément sont uniquement végétales, contrairement aux proportions recommandées de 6% d'origine végétale et 6% d'origine animale. Malgré l'ajout de compléments vitaminiques, les farines analysées sont très pauvres en micronutriments. En outre, une densité énergétique inadéquate des bouillies issues de la préparation de certaines farines les rend incapables d'assurer une alimentation suffisante pour la croissance du jeune enfant. Il ressort néanmoins, une standardisation des méthodes de fabrication de ces aliments de complément, expliquant l'absence de variation des paramètres étudiés d'un lot à un autre, à l'exception de la teneur en matières sèches. Des propositions d'amélioration de la densité énergétique des bouillies, ainsi que de la formulation des recettes et de leur préparation ont été suggérées à l'égard des entreprises productrices de farines infantiles de complément au Bénin

Detection of Poor Quality Artemisinin-based Combination Therapy (ACT) Medicines Marketed in Benin Using Simple and Advanced Analytical Techniques.

BACKGROUND: Poor quality antimalarial medicines still represent a threat to the public health, especially in Sub-Saharan Africa which bears a disproportionate share of the global burden of malaria. It is essential and urgent to strengthen mechanisms against counterfeit medicines. One of the approaches is regular market surveillance through quality controls. METHODS: 12 samples of artemether/lumefantrine were collected from formal and informal drug sellers in Cotonou (Benin) as well as additional other similar samples from Rwanda (13 samples) and from D.R. Congo (9 samples). Thin Layer Chromatography (TLC) as classical and simple identification test was applied in Benin while an analytical chemistry laboratory in Belgium (ULg, Pharmacy Department) was asked for further analyses with HPLC and Raman spectroscopy using a developed and validated HPLC method for rapid analysis of artemether/lumefantrine. RESULTS: The results obtained in Belgium confirmed the lack of the two active ingredients in the suspected sample of ACT medicine from Benin whereas some samples from Rwanda and D.R. Congo were found to present risk of substandard drugs either for under-dosing or over-dosing. CONCLUSIONS: Counterfeit/falsified of artemisinin-based combination therapy (ACT) medicines are really scourge that needs to be fought through strong collaboration between public health authorities and appropriate quality control laboratories.

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations.

As one of the world's most significant public health challenges in low- and middle-income countries, HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from counterfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviral medicines (ARV) and 4 major excipients. Design of experiments and design space methodology were initially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations and focusing on rapidity and affordability thus using short column and low cost organic solvent (methanol) in gradient mode with 10mM buffer solutions of ammonium hydrogen carbonate. Two other specific methods dedicated to ARV in liquid and in solid dosage formulations were also predicted and optimized. We checked the ability of one method for the analysis of a fixed-dose combination composed by emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtained by applying the total error approach taking into account the accuracy profile as decision tool. Then, the validated method was applied to test two samples coded A and B, and claimed to contain the tested ARV. Assay results were satisfying only for sample B.

Beninese Medicinal Plants as a Source of Antimycobacterial Agents: Bioguided Fractionation and In Vitro Activity of Alkaloids Isolated from Holarrhena floribunda Used in Traditional Treatment of Buruli Ulcer.

Buruli ulcer (BU) imposes a serious economic burden on affected households and on health systems that are involved in diagnosing the disease and treating patients. Research is needed to find cost-effective therapies for this costly disease. Plants have always been an important source of new pharmacologically active molecules. Consequently we decided to undertake the study of plants used in traditional treatment of BU in Benin and investigate their antimycobacterial activity as well as their chemical composition. Extracts from forty-four (44) plant species were selected on account of reported traditional uses for the treatment of BU in Benin and were assayed for antimycobacterial activities. Crude hydroethanolic extract from aerial parts of Holarrhena floribunda (G. Don) T. Durand and Schinz was found to have significant antimycobacterial activity against M. ulcerans (MIC = 125 µg/mL). We describe here the identification of four steroidal alkaloids from Mycobacterium ulcerans growth-inhibiting fractions of the alkaloidal extract of the aerial parts of Holarrhena floribunda. Holadysamine was purified in sufficient amount to allow the determination of its MCI (=50 µg/mL). These results give some support to the use of this plant in traditional medicine.

Buruli ulcer: a review of in vitro tests to screen natural products for activity against Mycobacterium ulcerans.

Buruli ulcer (BU), caused by Mycobacterium ulcerans, has recently been recognized by the World Health Organization (WHO) as an important emerging disease. It is largely a problem of the poor in remote rural areas and has emerged as an important cause of human suffering. While antimycobacterial therapy is often effective for the earliest nodular or ulcerative lesions, for advanced ulcerated lesions, surgery is sometimes necessary. Antimycobacterial drugs may also prevent relapses or disseminated infections. Efficient alternatives different from surgery are presently explored because this treatment deals with huge restrictive factors such as the necessity of prolonged hospitalization, its high cost, and the scars after surgery. Traditional treatment remains the first option for poor populations of remote areas who may have problems of accessibility to synthetic products because of their high cost. The search for efficient natural products active on M. ulcerans should then be encouraged because they are part of the natural heritage of these populations; they are affordable financially and can be used at the earliest stage. This review provides a number of tests that will help to evaluate the antimycobacterial activity of natural products against M. ulcerans, which are adapted to its slow growing rate, and lists active extracts published up to now in Medline.